Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma
16 Years
90 Years
Both
Malignant Melanoma
Trial Information
Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma
The primary objectives of this phase II multicenter trial are to:
Determine the 1 and 2-year survival of patients treated according to protocol. Assess the
safety and toxicity of this regimen in this patient population.
The secondary objectives are to:
Determine the freedom from progression (FFP). Measure the response rate (RR). Obtain
immunological data from the use of this regimen in vivo (as separate project: Moffitt?).
The proposed study is a multicenter phase II trial of HD-IL-2 in combination with GM-CSF.
GM-CSF will be started 7 days before day 1 of HD-IL-2 and will be continued for 4 weeks to
day 28, encompassing two cycles of HD-IL2. The first 9 patients will be closely monitored
for unexpected toxicity.
Inclusion Criteria:
- Histologically confirmed diagnosis of melanoma with measurable disease
- Patients with stage IV or unresectable advanced melanoma
- Age at least 16 years.
- ECOG performance status of 0-1
- Life expectancy > 3 months
- Adequate major organ function to tolerate therapy, as defined by:
- Total bilirubin 2.0 mg/dL.
- Creatinine 1.8 mg/dL.
- WBC 3,000/mm3.
- Platelet count 100,000/mm3.
- Patients 50 years of age with one or more cardiac risk factors must demonstrate
normal exercise stress test, stress thallium test, or comparable cardiac ischemia
evaluation
- Left ventricular ejection fraction > 40%
- Women of childbearing age must agree to use barrier method birth control and
demonstrate a negative pregnancy test prior to initiation of protocol therapy.
Periodic negative urine pregnancy tests will also be required.
- Patients must give written informed consent
Exclusion Criteria:
- No prior HD- IL-2 for stage IV/unresectable advanced disease. Prior low dose IL-2 is
allowed.
- No more than 2 prior chemotherapy regimens are allowed.
- No active CNS metastases. Treated CNS metastases without recurrence or progression
for > 8 weeks are allowed.
- No concurrent use of systemic corticosteroids
- Pregnant and/or lactating are excluded
- No concurrent antineoplastic treatments, including chemotherapy, biologic response
modifiers, radiation, vaccines, or other experimental therapies.
- No treatment for melanoma within the previous 4 weeks.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary Objective
Outcome Description:
Determine the 1 and 2-year survival of patients treated according to protocol. Assess the safety and toxicity of this regimen in this patient population
Outcome Time Frame:
one - two years
Safety Issue:
No
Principal Investigator
Jose Lutzky, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Mount Sinai Medical Center Miami Beach
Authority:
United States: Institutional Review Board
Study ID:
MEL0105
NCT ID:
NCT00616564
Start Date:
February 2006
Completion Date:
September 2009
Related Keywords:
- Malignant Melanoma
- GM-CSF
- Interleukin
- IL-2
- Sargrostim
- Melanoma
Name | Location |
|---|---|
| Jose Lutzky, MD | Miami Beach, Florida 33140 |
| David Lawson, MD | Atlanta, Georgia 30322 |
